US ADHD Stimulant Shortage Highlights Growing Challenges in Adult Treatment

Accessing ADHD treatment presents numerous challenges for many adults. | Image Credit: © Kwangmoozaa - stock.adobe.com

The ongoing shortage of stimulant medications has exposed critical gaps in the treatment of attention-deficit/hyperactivity disorder (ADHD), particularly for adults, in whom rising diagnoses, stigma, and limited clinical guidance complicate care.¹ Patients face mounting barriers to care, highlighting the urgent need for improved diagnostics, evidence-based guidelines, and equitable access to medications.

While name brands like Adderall and Vyvanse may have been recently removed from the FDA Drug Shortage Database, it's unclear if it'll last; meanwhile, many generic forms of ADHD medication are still in short supply.^2,3

The COVID-19 pandemic has reshaped trends in ADHD treatment, with heightened demands on attention and expanded access to telehealth contributing to an increase in adult diagnoses, according to an article in JAMA Psychiatry.¹ However, diagnosing ADHD in adults remains complex. Originally perceived as a childhood disorder, ADHD is now recognized as a lifelong condition, affecting an estimated 2.5% to 4% of adults in the US and costing over $100 billion annually.

Diagnostic criteria—adapted from pediatric guidelines—may not adequately capture adult-specific symptoms, such as deficits in executive function or challenges in emotional regulation. This can lead to potential misdiagnosis or underdiagnosis, the authors explained.

Accessing treatment presents numerous challenges for many adults. Concerns about medication misuse, social stigma, and a lack of long-term data on treatment outcomes complicate care. Another challenge is that health systems, clinicians, and policy makers are grappling with how to balance the benefits of effective treatment against the risks of diversion and stimulant use disorder.

Stimulants are widely regarded as the most effective treatment for ADHD, although nonstimulants and behavioral therapies are often underutilized, the authors argued. The absence of evidence-based treatment guidelines further undermines clinicians’ confidence in prescribing, resulting in risks of both overtreatment and undertreatment. Moreover, medication shortages have highlighted disparities in access to care.

In September, the federal Drug Enforcement Agency (DEA) approved a production increase for Vyvanse (lisdexamfetamine) and its generic equivalents, raising the aggregate production quota (APQ) for the stimulant medication by approximately 24%.⁴ This decision aimed to address the rising demand for ADHD and binge-eating disorder treatments.

However, discussions on the topic haven't led to confidence in the ability to significantly alleviate the ongoing stimulant shortage, with many largely attributing the issue to DEA-imposed production caps.

Vyvanse, which became available as a generic in August 2023, converts to dextroamphetamine in the body, the same active ingredient in Adderall. While the DEA also raised the APQ for dextroamphetamine by 18%, only about 25% of the increased quota will be allocated for domestic use, equating to just a 6.5% rise in lisdexamfetamine supply for the US. Despite higher demand—estimated by the FDA to have grown 6% from 2023 to 2024—the production adjustment falls short of bridging the supply gap.

The stimulant shortage began with Adderall supply issues in October 2022 and has since impacted other ADHD medications like Vyvanse and Ritalin. Although some Adderall manufacturers, like Teva Pharmaceuticals, have made progress in recovering inventory, Vyvanse's manufacturers and its generics face persistent challenges. The DEA’s caps on dextroamphetamine, cited as the primary reason for shortages, limit manufacturers’ ability to meet demand even after Vyvanse’s patent expired and generic versions became available.

The DEA and FDA have acknowledged the challenges but emphasize their limited authority, stating they cannot mandate pharmaceutical companies to produce more or alter distribution practices. Critics argue that the DEA’s yearly quotas, described as arbitrary and restrictive, are a root cause of the ongoing shortages. Adjustments to these caps, they claim, could resolve the supply issues without requiring additional regulatory intervention.

However, William Dodson, MD, LF-APA, stated in a blog post for ADDitude that the system utilized by the DEA is designed to combat potential abuse and, therefore, is inflexible and unable to adapt to changing patient needs.⁵ The DEA establishes annual production caps for each pharmaceutical company based on predictions made nearly 2 years in advance.

"By inviting public testimony on the stimulant shortage and pharmaceutical practices, I believe the FTC [Federal Trade Commission] is only trying to find cover for the [DEA]," Dodson wrote. "The DEA is the only governmental agency that sets production and distribution quotas for every drug company manufacturing controlled medication. The DEA decides how much of each medication can be released to pharmacies in any given month. Therefore, this problem traces its roots and long tendrils back to the DEA alone. No other agency has the authority to create and prolong it."

Critics noted that the DEA’s 2022 decision to impose tighter quotas on ADHD medications stemmed from concerns about diversion and misuse—despite limited evidence supporting these claims. Dodson further explained that research has suggested that most stimulant misuse occurs among a narrow demographic of white male college students, not individuals with ADHD, who rely on these medications for daily functioning.

The shortage worsened as the DEA restricted supply following a surge in adult ADHD diagnoses. Despite well-documented evidence that ADHD persists into adulthood, the DEA’s response seemingly ignored this reality, reducing medication availability as demand grew.

Initially, the DEA and other agencies, including the FDA and FTC, attributed the shortage to manufacturing and raw material shortages. However, pharmaceutical companies have consistently stated they are producing as much as the DEA permits. Telemedicine clinics, cited as a contributing factor during the pandemic, accounted for only a fraction of prescriptions and have largely ceased operations. Despite these deflections, the shortage remains unresolved, causing significant disruption for patients reliant on these medications.

Critics call for the DEA to overhaul its flawed quota system and prioritize patient needs over unfounded concerns about abuse. Without swift action, the shortage will persist into 2025, prolonging unnecessary suffering for millions.

"The idea that the drug companies were forgoing billions of dollars of profit was always unbelievable," Dodson wrote. "Then the blame was laid on raw material shortages, but after two years, that explanation became hard to believe as well... The time has long since passed for the DEA to admit its fault and fix its broken quota system."

References

1. Blanco C, Surman CBH. Diagnosing and treating ADHD in adults: balancing individual benefits and population risks. JAMA Psychiatry. Published online October 23, 2024. doi:10.1001/jamapsychiatry.2024.3228

2. FDA drug shortages. FDA. Accessed November 25, 2024. https://dps.fda.gov/drugshortages

3. Teva's Adderall makes it off the FDA shortage list while generic ADHD med supply squeeze persists. Fierce Pharma. May 22, 2024. Accessed November 26, 2024. https://www.fiercepharma.com/manufacturing/tevas-adderall-makes-it-fda-shortage-list-while-generic-adhd-med-supply-squeeze

4. Wolkoff Wachsman M. Vyvanse shortage update: DEA OKs expanded production of the ADHD medication. ADDitude. September 12, 2024. Accessed November 25, 2024. https://www.additudemag.com/vyvanse-shortage-lisdexamfetamine-dimesylate-adhd-medication/

5. Dodson W. The DEA's manufactured crisis. ADDitude. July 10, 2024. Accessed November 27, 2024. https://www.additudemag.com/adderall-shortage-dea-stimulants-adhd-medication/